• Konstantinos Katsanos, Dimitris Karnabatidis, Panagiotis Kitrou, Stavros Spiliopoulos, Nikolaos Christeas, and Dimitris Siablis.
• Department of Diagnostic and Interventional Radiology, Patras University Hospital, School of Medicine, Rion, Greece. katsanos@med.upatras.gr
• J. Endovasc. Ther. 2012 Apr 1; 19 (2): 263-72.

PurposeTo report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG).MethodsThe enrollment criteria for this non-inferiority hypothesis trial included clinical signs of failing dialysis access with angiographic documentation of a significant venous stenotic lesion in patients with AVF or AVG circuits. From March to December 2010, 40 patients (29 men; mean age 64.1 ± 14.3 years) were randomized to undergo either PCB dilation (n = 20) or standard BA (n = 20) of a stenosed venous outflow lesion. Regular angiographic follow-up was scheduled bimonthly. Study outcome measures included device success (<30% residual stenosis without postdilation), procedural success (<30% residual stenosis), and primary patency of the treated lesion (<50% angiographic restenosis and no need for any interim repeat procedures).ResultsBaseline and procedural variables were comparably distributed between both groups. Device success was 9/20 (45%) for the PCB device vs. 20/20 (100%) for standard control BA (p<0.001). Procedural success was 100% in both groups after further high-pressure post-dilation as necessary. There were no major or minor complications in either group. At 6 months, cumulative target lesion primary patency was significantly higher after PCB application (70% in PCB group vs. 25% in BA group, p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006).ConclusionPCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis.

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